Case Study
C2DX, INC. IMPRESSES AUDITORS AND ACHIEVES MDSAP CERTIFICATION AFTER IMPLEMENTING MEDICAL DEVICE QMS (MDQMS)
C2DX, INC. IMPRESSES AUDITORS AND ACHIEVES MDSAP CERTIFICATION AFTER IMPLEMENTING MEDICAL DEVICE QMS (MDQMS)
After acquiring a product [from Stryker], the experienced team of medical device professionals at Critical Care Diagnostics (C2DX), Inc. knew they had to ensure 4 things to be successful: 1. Establish a quality-first approach to the company’s culture 2. Complete the acquisition and continue delivering a high-quality device 3. Quickly implement an electronic quality management system that could act as a foundation for both their initial needs and future growth 4. Provide the same customer experience customers had grown to expect from Stryker After previously starting and operating two medical devices companies, Kevin McLeod, CEO of C2DX, Inc., came across the opportunity to acquire a product used for diagnosing Compartment Syndrome — known as the STIC Intra-Compart- mental Pressure